Recall Z-0089-2017
Ortho-Clinical Diagnostics · initiated August 11, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
VITROS Chemistry Products GLU Slides, REF/Product Code 170 7801 (300 slides per sales unit), Unique Device Identifier No. 10758750009572, Rx ONLY, IVD --- For in vitro diagnostic use only. VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System
Codes / lots: Current/In-date GENs 10, 11, 20 through 31
Reason for recall
Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplement, can interfere with VITROS GLU, LAC, TRIG, and URIC Slides assays. Ortho also tested several compounds following industry standard CLSI EP7-A2 for potential interference on VITROS GLU Slides during validation testing for a proposed change and confirmed Dextran 40 and Glutathione may interfere with current VITROS GLU Slides.
FDA-determined cause: Under Investigation by firm
Action taken
Ortho-Clinical Diagnostics sent an URGENT PRODUCT CORRECTION Letter (Ref. CL2016-152) dated August 11, 2016 via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/or US Postal Service Priority Mail (for PO Boxes only) to all customers who could order and use affected product to inform them that new interferant were identified for GLU, LAC, TRIG and URIC Slides which may cause biased results. Foreign affiliates were informed by e-mail on August 11, 2016, of the issue and instructed to notify their consignees of the issue. For questions, please contact our Ortho CareTM Technical Solutions Center at 1-800-421-3311. For questions regarding this recall call 908-218-8776.
Details
- Recall number
- Z-0089-2017
- Initiated
- August 11, 2016
- Terminated
- June 11, 2018
- Product code
- CGA – Glucose Oxidase, Glucose
- Quantity
- US: 192,459 sales units; Foreign: 231,710 sales units
- Distribution
- Worldwide Distribution - US (Nationwide) Puerto Rico and Bermuda), Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Poland, Singapore, Spain, and Venezuela.
- Recalling firm
- Ortho-Clinical Diagnostics, Rochester, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0090-2017 Class II | VITROS Chemistry Products LAC Slides, REF/Product Codes 843 3880 (300 slides per sales…Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose… | 08/11/2016Terminated |
| Z-0091-2017 Class II | VITROS Chemistry Products TRIG Slides, REF/Product Codes 133 6544 (300 slides per sales…Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose… | 08/11/2016Terminated |
| Z-0092-2017 Class II | VITROS Chemistry Products URIC Slides, REF/Product Code 194 3927 (300 slides per sales…Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose… | 08/11/2016Terminated |