Recall Z-1847-2025
Mckesson Medical-Surgical Inc. Corporate Office · initiated April 24, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ABBOTT DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS REAGENT.
Codes / lots: Catalog No. 04P5325; GTIN: 380740007775; Order No. 46061983.
Reason for recall
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
FDA-determined cause: Storage
Action taken
An URGENT PRODUCT RECALL notification dated 4/21/25 was mailed to consignees. The notification instructs consignees to immediately examine their inventory and quarantine all product identified as subject to this recall action. Consignees are asked to return the completed response form to MMSQARecalls@McKesson.com and to destroy any quarantined devices. Questions about this recall can be directed to 1-800-688-8840 from 8:00 am to 5:00 pm Monday through Friday. If product has been further distributed, consignees are asked to forward the provided recall notice to those customers.
Details
- Recall number
- Z-1847-2025
- Initiated
- April 24, 2025
- Posted by FDA
- May 27, 2025
- Product code
- LOM – Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Quantity
- 400 units
- Distribution
- US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1824-2025 Class II | ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROLtransit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | 04/24/2025Open, Classified |
| Z-1825-2025 Class II | ABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS) CASSETTES.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | 04/24/2025Open, Classified |
| Z-1826-2025 Class II | ABBOTT RAPID DX N AMERICA LLC CHOLESTECH LDX LIPID PROFILE+GLUCOSE (10/BX 50BX/CS) TEST.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | 04/24/2025Open, Classified |
| Z-1827-2025 Class II | HEMOCUE INC F/GLUCOSE 201 ANALYZER (25/VL 4VL/BX) MICROCUVETTE.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | 04/24/2025Open, Classified |
| Z-1828-2025 Class II | BD MICROBIOLOGY FLUID THIOGLYCOLLATE MED TUBE 1004321196 (100/CT) MEDIA.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | 04/24/2025Open, Classified |
| Z-1829-2025 Class II | BD MICROBIOLOGY MAC CONKEY II AGAR (100/CT) 21270 MEDIA.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | 04/24/2025Open, Classified |
| Z-1830-2025 Class II | ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | 04/24/2025Open, Classified |
| Z-1831-2025 Class II | ORTHO CLINICAL DIAGNOSTICS INC VITROS CALCIUM (L-SEQUESTER) (300/PK) REAGENT.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | 04/24/2025Open, Classified |
| Z-1832-2025 Class II | ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS (60/CR 5CR/PK) ORCLNL REAGENT.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | 04/24/2025Open, Classified |
| Z-1833-2025 Class II | ORTHO CLINICAL DIAGNOSTICS INC VANCOMYCIN (300/BX)ORCLNL REAGENT.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | 04/24/2025Open, Classified |
| Z-1834-2025 Class II | ORTHO CLINICAL DIAGNOSTICS INC FS(3PK/BX)ORCLNL DILUENT PACK 3.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | 04/24/2025Open, Classified |
| Z-1835-2025 Class II | ORTHO CLINICAL DIAGNOSTICS INC TOTAL BILI-ALKP XT (L-SEQUESTER) (300/PK) REAGENT.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | 04/24/2025Open, Classified |
| Z-1836-2025 Class II | ORTHO CLINICAL DIAGNOSTICS INC ANTI-B BIOCLONE 10ML3X10ML.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | 04/24/2025Open, Classified |
| Z-1837-2025 Class II | ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) ORCLNL REAGENT.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | 04/24/2025Open, Classified |
| Z-1838-2025 Class II | HEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE CONTROL.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | 04/24/2025Open, Classified |
| Z-1839-2025 Class II | HEMOCUE INC HEMOTROL HIGH 2X1ML LEVEL 3 HEMCUE CONTROL.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | 04/24/2025Open, Classified |
| Z-1840-2025 Class II | ABBOTT DIAGNOSTICS ARC CARBON DIOXIDE6X5ML B CALIBRATOR.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | 04/24/2025Open, Classified |
| Z-1841-2025 Class II | ABBOTT DIAGNOSTICS PROBE CONDITIONING F/ARCHITECT ANLYZ ABBDIA SOLUTION.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | 04/24/2025Open, Classified |
| Z-1842-2025 Class II | ABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) REAGENT.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | 04/24/2025Open, Classified |
| Z-1843-2025 Class II | ABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B REAGENT.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | 04/24/2025Open, Classified |
| Z-1844-2025 Class II | ABBOTT DIAGNOSTICS ARC T-UPTAKE ASSAY (100TST/BX) ABBDIA REAGENT.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | 04/24/2025Open, Classified |
| Z-1845-2025 Class II | ABBOTT DIAGNOSTICS ARCHITECT HIV COMBO 1X4ML CALIBRATOR.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | 04/24/2025Open, Classified |
| Z-1846-2025 Class II | ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | 04/24/2025Open, Classified |
| Z-1848-2025 Class II | ABBOTT DIAGNOSTICS ARCHITECT VITAMIND 6LEVEL CALIBRATOR.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | 04/24/2025Open, Classified |
| Z-1849-2025 Class II | ABBOTT DIAGNOSTICS ARCHITECT TOTAL T36X4ML CALIBRATOR.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | 04/24/2025Open, Classified |
| Z-1850-2025 Class II | ABBOTT DIAGNOSTICS ARCHITECT FREE T4ABBDIA CALIBRATOR.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | 04/24/2025Open, Classified |
| Z-1851-2025 Class II | ABBOTT DIAGNOSTICS ARCHITECT PROGESTERONE (100TESTS) REAGENT.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | 04/24/2025Open, Classified |
| Z-1852-2025 Class II | ABBOTT DIAGNOSTICS ALINITY I FREE PSA US(200TEST/EA) REAGENT.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | 04/24/2025Open, Classified |
| Z-1853-2025 Class II | ABBOTT DIAGNOSTICS ALINITY I ANTI-CCPS REAGENT.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | 04/24/2025Open, Classified |
| Z-1854-2025 Class II | SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | 04/24/2025Open, Classified |