# FDA recall Z-1322-2018

> **Clinical Diagnostic Systems** · Class III · device recall initiated 2018-01-11.

## Product

VITROS Immunodiagnostic Products TSH Reagent Pack

## 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.

## 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.

## Key facts

- **Recall number:** Z-1322-2018
- **Recalling firm:** Clinical Diagnostic Systems
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-11
- **Report date:** 2018-04-18
- **Termination date:** 2020-09-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rochester, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1322-2018

## Citation

> AI Analytics. FDA recall Z-1322-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1322-2018. Source: US FDA. Licensed CC0.

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