Ortho Clinical Diagnostics Inc: VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an assayed control used to monitor

Is my product affected?

VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated System - Product Code: 82

• UPC 10758750004577

Check against the official notice below — it lists the full affected range.

What happened

Ortho Clinical Diagnostics Inc. has recalled VITROS Chemistry Products Performance Verifier II Lot Q7692 (expiration date November 1, 2021) due to product instability that causes biased alkaline phosphatase (ALKP) values when the product is stored unopened at refrigerated temperatures. This control product is used to monitor performance of VITROS Chemistry diagnostic equipment. Approximately 10,788 units were distributed worldwide, including 4,680 units in the US and 6,108 units internationally across Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, and the United Kingdom.

The source document does not specify what actions affected consumers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated temperatures

Details from the source

Reason for recall: Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated temperatures Distribution: Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom. Quantity: 10788 total: US 4680; OUS 6108 Lot/code info: Lot Q7692 , EXP: 01-NOV-2021 UDI: 10758750004577

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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