Recall Z-1849-2011

Hemo Cue, Inc. · initiated October 7, 2010

Terminated

Product

HEMOCUE AB Hb 201 DM ANALYZER, in vitro diagnostic device for quantitative hemoglobin determination.

Codes / lots: HemoCue Hb 201 DM Analyzers, (USA): Serial Numbers: 0632620050; 0647620080, 0717620162 & 0717620185; 0650620105; 0717620156; 0717620169; 0717620186; 0647620088; 0717620170; 0717620157 & 0717620187; 0647620104, 0650620077, 0650620081, 0650620104, 0706620010, 0706620032, 0706620043, 0706620057, 0706620094, 0709620025 & 0709620031; 0650620066; 0650620112; 0717620152, 0717620153 & 0717620172; 0706620041; 0717620189; 0717620190; 0717620158; 0702620049; 0717620155; 0717620115; 0717620178 & 0717620179; 0717620159; 0717620065 & 0717620174; 0717620165; 0717620181; 0717620167; 0706620019 & 0706620020; 0717620171, 0717620173 & 0717620184; 0717620131; 0717620166, 0717620160, 0717620168 & 0717620180. HemoCue Hb 201 DM Analyzers, (Europe): Serial Numbers: 0630630060; 0639620042; 0640620003 & 0640620015; 0717620197; 0717620199; 0717620183; 0717620191; 0717620200; 0709620026 & 0709620121; 0709620050, 0709620097, 0717620193, 0717620194, 0717620195 & 0717620196; 0717620163 & 0717620164; 0709620034; 0709620023; 0717620198; 0647620069.

Reason for recall

Incorrect configurations settings in software. As a result, certain error codes do not trigger appropriately. These error codes are: E01, E02 and E05 which are all related to the optronic performance of the analyzer. Possible incorrect results.

FDA-determined cause: Process control

Action taken

Hemocue AB sent Customer Notification "Notice of Medical Device Correction on HemoCue Glucose 201 DM and HemoCue Hb 201 DM Analyzers" dated October 7, 2010, to customers notifying them of incorrect settings on error codes. The corrective action consists of an update of the configuration settings on the the affected HemoCue Glucose 201 DM and Hb 201 DM analyzers that are in the field. The affected units in the field will be corrected in accordance with a rework procedure that has been established by HemoCue AB.

Details

Recall number
Z-1849-2011
Initiated
October 7, 2010
Posted by FDA
March 30, 2011
Terminated
June 22, 2011
Product code
GKR – System, Hemoglobin, Automated
Quantity
79
Distribution
Worldwide distribution, including USA, and Glucose 201 DM analyzers to Norway and the Netherlands; Hb 201 DM analzyers to the Netherlands, France, Ireland, Great Britain, Poland and Germany.
Recalling firm
Hemo Cue, Inc., Cypress, CA

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1848-2011 HEMOCUE AB GLUCOSE 201 DM ANALYZER, in vitro diagnostic device for quantitative…Incorrect configurations settings in software. As a result, certain error codes do not trigger… 10/07/2010Terminated