Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-sera is for the control of accuracy.
FDA Recall Z-2150-2019 · Posted None
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Recalling FirmRandox Laboratories, Limited
Recall StatusTerminated
Product CodeJJY
Date Initiated2019-06-11
Date Terminated2020-05-15
Product Quantity149 (US)
Reason for Recall
The RX Series control target and range value for ALT (Tris buffer without P5P 37C), Bicarbonate and Gamma-GT has been incorrectly assigned in specific lots of the Human Assayed Multi-Sera Controls.
Firm Action
On May 25, 2019, the firm notified its customers of the recall via Urgent Medical Device Correction letters. Customers were instructed to do the following:
" Review your reagent inventory of these products. Remove all previous versions of the
Value Sheets in use and replace with the revised version.
" Discuss the contents of this notice with your Medical Director.
" Complete and return the response form 12187-QA to t echnical.services@ randox.com
within five working days.
If you have any questions or concerns, please contact Randox Technical
Services.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide Distribution - AZ CA CT FL GA IL KY LA MA MD MI MN MO NJ NY OH OK OR PA TX UT VA WA WI WV and PR. Worldwide foreign distribution.
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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