Recall Z-1660-2018
Siemens Healthcare Diagnostics, Inc. · initiated June 29, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Dimension Vista Thyroxine (T4) assay; (Product Number: K6065/10445101) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Codes / lots: All lots
Reason for recall
Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results.
FDA-determined cause: Device Design
Action taken
Letters were sent to consignees with the following instructions: " Please review this letter with your Medical Director. " Venipuncture should occur before drug administration of Sulfasalazine or Sulfapyridine as indicated above under Reason For Correction. Baseline assay values before administration of Sulfasalazine or Sulfapyridine therapy would not be affected. " Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. " If you have received any complaints of illness or adverse events associated with the products listed in Table 1 or 2, immediately contact your local Siemens Customer Care Center or your local Siemens technical support representative.
Details
- Recall number
- Z-1660-2018
- Initiated
- June 29, 2017
- Terminated
- April 23, 2020
- Product code
- KLI – Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- Quantity
- 19,991
- Distribution
- Distributed in all 50 U.S. states, the District of Columbia, Guam, and Puerto Rico. Distributed in 108 foreign countries: Afghanistan Bolivia Albania¿¿¿¿¿¿¿¿ Algeria¿¿¿¿¿¿¿¿ Angola ARGENTINA Armenia AUSTRALIA Austria¿¿¿¿¿¿¿¿ Azerbaijan Bahamas Bahrain¿¿¿¿¿¿¿¿ Bangladesh¿¿¿¿¿ Belarus¿¿¿¿¿¿¿¿ Belgium¿¿¿¿¿¿¿¿ Bosnia¿Herzeg.¿ Brazil Bulgaria¿¿¿¿¿¿¿ Cambodia Canada Canary islands Chile China Colombia…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., Tarrytown, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1646-2018 Class II | ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended to…Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may… | 06/29/2017Terminated |
| Z-1647-2018 Class II | ADVIA Alanine Aminotransferase (ALT) reagent chemistry assays; ALT intended to measure…Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may… | 06/29/2017Terminated |
| Z-1648-2018 Class II | ADVIA Salicylate (SAL) reagent chemistry assay; use in the quantitative determination of…Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may… | 06/29/2017Terminated |
| Z-1649-2018 Class II | Dimension Ammonia (AMM) assay; (Product Number: DF119/10711991) (Mfr: Siemens Healthcare…Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may… | 06/29/2017Terminated |
| Z-1650-2018 Class II | Dimension Alanine Aminotransferase (ALTI) assay; (Product Number: DF143/10475530) (Mfr:…Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may… | 06/29/2017Terminated |
| Z-1651-2018 Class II | Dimension Aspartate Aminotransferase (AST) assay (Product Number: DF41A/10444959) (Mfr:…Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may… | 06/29/2017Terminated |
| Z-1652-2018 Class II | Dimension Glucose (GLUC) assay (Product Number: DF40/10444973) (Mfr: Siemens Healthcare…Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may… | 06/29/2017Terminated |
| Z-1653-2018 Class II | Dimension Creatine Kinase MB (MBI) assay (Product Number: DF32/10464510) (Mfr: Siemens…Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may… | 06/29/2017Terminated |
| Z-1654-2018 Class II | Dimension Thyroxine (T4) assay (Product Number: DF65/10444908) (Mfr: Siemens Healthcare…Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may… | 06/29/2017Terminated |
| Z-1655-2018 Class II | Dimension Vista Ammonia (AMM) assay (Product Number: K3119/10711992) (Mfr: Siemens…Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may… | 06/29/2017Terminated |
| Z-1656-2018 Class II | Dimension Vista Alanine Aminotransferase (ALTI) assay; (Product Number: K2143/10635565)…Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may… | 06/29/2017Terminated |
| Z-1657-2018 Class II | Dimension Vista Aspartate Aminotransferase (AST) assay; (Product Number: K2014/10445148)…Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may… | 06/29/2017Terminated |
| Z-1658-2018 Class II | Dimension Vista Glucose (GLU) assay; (Product Number: K1039/10445162) (Mfr: Siemens…Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may… | 06/29/2017Terminated |
| Z-1659-2018 Class II | Dimension Vista Creatine Kinase MB (MBI) assay; (Product Number: K3032/10464339) (Mfr:…Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may… | 06/29/2017Terminated |
| Z-1661-2018 Class II | Syva Emit 2000 Tacrolimus Assay (Product Number: 8R019UL/10445397) (Mfr: Siemens…Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may… | 06/29/2017Terminated |
| Z-1662-2018 Class II | Syva Emit 2000 Sirolimus Assay (Product Number: 8S019UL/10445401) (Mfr: Siemens…Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may… | 06/29/2017Terminated |