Clinical Diagnostic Systems: Medical Device Recall in 2018 - (Recall #: Z-1322-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

VITROS Immunodiagnostic Products TSH Reagent Pack

Product Classification:

Class III

Date Initiated: January 11, 2018

Date Posted: April 18, 2018

Recall Number: Z-1322-2018

Event ID: 79508

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.

Status: Terminated

Product Quantity: Lot #5470 (US=8570/OUS=537); Lot #5430 (US=0/OUS=9135); Lot #5178 (US=5178/OUS=4396)

Code Information:

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,

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated