FDA Device recall Z-1322-2018
VITROS Immunodiagnostic Products TSH Reagent Pack
- FDA Device
- Class III
- terminated
- Published 2018-04-18
On 2018-04-18 the FDA classified a Class III recall of VITROS Immunodiagnostic Products TSH Reagent Pack by Clinical Diagnostic Systems, citing 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 tha….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1322-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-01-11 |
| Published | 2018-04-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Clinical Diagnostic Systems |
| Distribution | n/a |
Product
VITROS Immunodiagnostic Products TSH Reagent Pack
Reason
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.
Identifiers
| code_info | Lot 5470, expiry date: 24-May-2018 Lot 5430, expiry date: 01-Mar-2018 (not distributed in the US.) Lot 5178 was also…Lot 5470, expiry date: 24-May-2018 Lot 5430, expiry date: 01-Mar-2018 (not distributed in the US.) Lot 5178 was also affected by this issue, expired on 31-Mar-2017, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1322-2018%22
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