Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053
FDA Recall Z-1785-2019 · Posted None
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Recalling FirmRandox Laboratories Ltd.
Recall StatusTerminated
Product CodeJJY
Date Initiated2019-03-11
Date Terminated2020-05-15
Product Quantity11420 kits
Reason for Recall
Customers may observe a decrease in recovered concentration with regards to NTproBNP in the Liquid Cardiac Control lots identified, on the Siemens Dimension EXL LOCI.
Firm Action
On March 11, 2019, the firm notified affected consignees of the product issue through an Urgent Medical Device Correction letter. Customers were informed that they may observe a decrease in recovered concentration for NTproBNP in the referenced Liquid Cardiac Control lots compared to the quoted target value on the value sheet for this analyzer only (Siemens Dimension EXL LOCI).
Customers were asked to do the following:
* Inspect your stock and quarantine affected stock.
" Replace the value sheet in the kit with the revised value sheet provided.
" Randox is not recommending a review of previous results as changes in quality control
recovery would be reviewed at the time of occurrence.
" Discuss the contents of this notice with your Medical Director.
" Complete the response form even if you no longer have the affected product. Return
the response form to [email protected] within five working days.
Root Cause
Under Investigation by firm
Distribution Pattern
Product distributed to CA, DE, WV, and Puerto Rico.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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