VITROS Immunodiagnostic Products TSH Reagent Pack
FDA device recall Z-1322-2018 · posted 2018-04-10 · Terminated
Recall details
- Recalling firm
- Clinical Diagnostic Systems
- Reason for recall
- VITROS TSH reagent lots have been found to generate higher than expected Calibrator level 2 signals on some customer systems. These Calibrator Level 2 responses cause a higher than expected frequency of customer generated calibration curves to fall outside of the calibration quality parameter measuring the gradient of the Customer Calibration Curve between Calibrator Level 2 and Calibrator Level 3.
- Action taken
- Distributors instructed to disgard remaining inventory, complete Confirmation of Receipt form, and firm promised to replace product. Distributors instructed to send letter to customers.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JLW
- Quantity affected
- Lot #5470 (US=8570/OUS=537); Lot #5430 (US=0/OUS=9135); Lot #5178 (US=5178/OUS=4396)
- Distribution
- Distributors were notified via letter. Lot 5430 was not distributed in the US. Lot 5178 was also affected by this issue, but this lot expired on 31-Mar-2017 so Ortho took no action on this lot.
- Date initiated
- 2018-01-11
- Date posted
- 2018-04-10
- Date terminated
- 2020-09-08
- Location
- Rochester, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM (K083173) | Ortho-Clinical Diagnostics | 2008-12-22 |