Z-1322-2018Class III

VITROS Immunodiagnostic Products TSH Reagent Pack

Name: Z-1322-2018 VITROS Immunodiagnostic Products TSH Reagent Pack
Creator: Clinical Diagnostic Systems
Published: 2018-01-11
License: https://open.fda.gov/license/

Clinical Diagnostic Systems, Inc. / initiated 2018-01-11 / Terminated / root cause: manufacturing process

FDA source

Clinical Diagnostic Systems began a recall of VITROS Immunodiagnostic Products TSH Reagent Pack on 2018-01-11. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1322-2018
Classification: Class III
Status: Terminated
Initiated: 2018-01-11
Posted: 2018-04-10
Terminated: 2020-09-08
Recalling firm: Clinical Diagnostic Systems, Inc.
Product: VITROS Immunodiagnostic Products TSH Reagent Pack
Product code: JLW Radioimmunoassay, Thyroid-Stimulating Hormone
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Distributors instructed to disgard remaining inventory, complete Confirmation of Receipt form, and firm promised to replace product. Distributors instructed to send letter to customers.
Quantity in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1322-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1322-2018	Class III	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-11

Product code JLW

K083173Class IIVitros Immunodiagnostic Products Tsh Reagent Pack and Calibrators, Vitros 3600 Immunodiagnostic SystemOrtho-Clinical Diagnostics / cleared 2008-12-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)