The VARIANT Sickle Cell Short Program ROM Card; Distributed by and Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA The VARIANT Sickle Cell Short Program is designed as a qualitative screen for the presence of hemoglobins F, A, S, D, C and E in eluates of neonatal blood collected on filter paper by high-performance liquid chromatography. For in vitro diagnostic use.
FDA Recall Z-1846-2011 · Posted 2011-03-29
Advertisement
Recalling FirmBio-Rad Laboratories Inc
Recall StatusTerminated
Product CodeGKA
Date Initiated2010-04-22
Date Terminated2011-04-07
Product Quantity10 units
Reason for Recall
The presence of parameters for Version 40400-S on the labeled VARIANT Sickle Cell Short ROM Card instead of Version 80300-S.
Firm Action
The firm, Bio-Rad, sent an "URGENT: MEDICAL DEVICE RECALL NOTIFICATION" letter dated April 22, 2010, to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory and quarantine the product; complete and return the MEDICAL DEVICE RECALL RETURN RESPONSE FORM via fax to: (510) 741-3954, Attn: Bio-Rad CSD Regulatory Affairs, and contact there regional Bio-Rad office for ROM Card replacement.
If you have any questions, contact Bio-Rad CSD Regulatory Affairs Department at 510-724-7000.
Root Cause
Other
Distribution Pattern
Worldwide distribution: USA including: MD, NJ and UT; and countries of: Italy and Singapore.
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.
Advertisement