FDA Medical Device Recalls (openFDA)
Hemo Cue, Inc.: HEMOCUE AB Hb 201 DM ANALYZER, in vitro diagnostic device for quantitative hemoglobin determination.
- Recall number
- Z-1849-2011
- Recalling firm
- Hemo Cue, Inc.
- Product
- HEMOCUE AB Hb 201 DM ANALYZER, in vitro diagnostic device for quantitative hemoglobin determination.
- Status
- Terminated
- Initiated
- 2010-10-07
- Posted
- 2011-03-30
- Terminated
- 2011-06-22
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K041234"]
- PMA numbers
- not on file
- Product code
- GKR
- Firm FEI
- 3005104838
- Firm city
- Cypress
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28