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Terminated

Liquid Cardiac Control CQ5053

FDA Recall Z-0937-2018 · Posted None

Recalling FirmRandox Laboratories, Limited
Recall StatusTerminated
Product CodeJJY
Date Initiated2017-08-08
Date Terminated2018-09-05
Product Quantity450 kits

Reason for Recall

Randox has confirmed that Troponin T and Troponin I in Liquid Cardiac quality control CQ5053 lot 4069CK does not meet the shelf-life claim in the product labelling. As the control may now fall outside the provided control ranges the product is to be recalled from the field.

Firm Action

A recall notice was issued to customers on August 1, 2017 instructing them to discontinue use of product, discard remaining product for reimbursement and provide documentation of destruction.

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

Nationally

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K110534RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3Randox Laboratories Limited · 2012-01-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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