Z-2580-2016Class III

VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191 2997, Unique Device...

Name: Z-2580-2016 VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191 2997, Unique Device...
Creator: Ortho-Clinical Diagnostics
Published: 2016-07-28
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2016-07-28 / Terminated / root cause: manufacturing process

FDA source

ORTHO-CLINICAL DIAGNOSTICS began a recall of VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191 2997, Unique Device Identifier No. 10758750000227, IVD ---... on 2016-07-28. FDA classified it as Class III and gives the reason as "A field correction was issued by the firm for VITROS TSH reagent lot 5040 due to a higher than expected frequency of customer calibration curves falling outside of the calibration quality parameters and therefore...". 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-2580-2016
Classification: Class III
Status: Terminated
Initiated: 2016-07-28
Posted: 2016-08-17
Terminated: 2018-06-11
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191 2997, Unique Device Identifier No. 10758750000227, IVD --- Ortho-Clinical Diagnostics Pencoed Bridgend CF35 5PZ UK For the in vitro quantitative measurement of thyroid stimulating hormone (TSH) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.
Product code: JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Reason for recall: A field correction was issued by the firm for VITROS TSH reagent lot 5040 due to a higher than expected frequency of customer calibration curves falling outside of the calibration quality parameters and therefore unusable to process samples. Customers using VITROS TSH Lot 5040 will potentially experience an unexpected increase in the unsuccessful calibrations potentially causing a delay in testing and reporting results for VITROS TSH.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Ortho Clinical Diagnostics sent an Important Product Correction Notification letter on July 28, 2016, via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers who received VITROS Immunodiagnostic Product TSH, Lot 5040 to inform them of the issue and the required actions. Instructions were provided to customers. Customers with questions were instructed to contact Ortho Care" Technical Solutions Center at 1-800-421-3311. Foreign affiliates were informed by e-mail on July 28, 2016, of the issue and instructed to notify their consignees of the issue and the required actions. For questions regarding this recall call 908-218-8776.
Quantity in commerce: Domestic: 2883, Foreign: 1261
Distribution: Worldwide Distribution - US to VA, WV, GA, TN, KY, MN, SD, AR, OK and Internationally to Canada
Product codes and lots: Lot 5040 (Expiry date 19 Dec 2016)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2580-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2580-2016	Class III	Terminated	Voluntary: Firm initiated	2016-08-24	2016-08-17

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)