ABL800 FLEX Series analyzer with FLEXQ module-equipped with software version 5.2 to 5.27
FDA Recall Z-0705-2007 · Posted 2007-04-06
Recalling FirmRadiometer America Inc
Recall StatusTerminated
Product CodeCHL
Date Initiated2007-01-16
Date Terminated2012-05-08
Product Quantity64 in U.S. & 1,281 to foreign accounts
Reason for Recall
In some situations pre-registered patient data is not reset when leaving the pre-registration mode in the software. This occurs when a Safe Pico blood sampler associated with a specific patient is pre-registered in the analyzer by scanning a barcode.
Firm Action
Radiometer America issued a recall letter to their U.S. customers dated 1/16/2007. The letter informs the customers of this software anomaly and the conditions underwhich analyzer results can be stored with incorrect Patient Demographics. The letter goes on to inform the customers that a Radiometer Service Representative will be visiting each customer location shortly in order to upgrade the affected software. In the meantime, the letter recommends that the customer(s) not pre-register their samples. The letter is accompanied by an attached FAX FORM which the customer is asked to sign and complete in order to verify receipt of the recall letter and to fax back to the recalling firm.
Root Cause
Other
Distribution Pattern
Worldwide Distribution-USA including states of NY, KS, SD, OH, TX, KY, NC, IL, MO, AL, UT, CO, CA, NM, and MI and Country of Denmark
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.