Z-1849-2011

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

Name: Z-1849-2011 HEMOCUE AB Hb 201 DM ANALYZER, in vitro diagnostic device for quantitative hemoglobin determination
Creator: Hemo Cue, Inc.
Published: 2010-10-07
License: https://open.fda.gov/license/

Hemo Cue, Inc. / initiated 2010-10-07 / Terminated / root cause: manufacturing process

FDA source

Hemo Cue, Inc. began a recall of HEMOCUE AB Hb 201 DM ANALYZER, in vitro diagnostic device for quantitative hemoglobin determination on 2010-10-07. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1849-2011
Status: Terminated
Initiated: 2010-10-07
Posted: 2011-03-30
Terminated: 2011-06-22
Recalling firm: Hemo Cue, Inc.
Product: HEMOCUE AB Hb 201 DM ANALYZER, in vitro diagnostic device for quantitative hemoglobin determination.
Product code: GKR System, Hemoglobin, Automated
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 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.
Product codes and 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.

Product code GKR

K041234Class IIHemocue Hemoglobin 201Dm Analyzing SystemHemocue, Inc. / cleared 2004-06-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)