FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corp.: ACCU-CHEK Complete diabetes monitoring kit/ care kit/ insulin pump therapy kit, Cat. no 515; Ref. nos. 03144852001 and 12031981001 with meter model no. 200 and Ref. no. 03144852001 with meter model no. 250.
- Recall number
- Z-1363-06
- Recalling firm
- Roche Diagnostics Corp.
- Product
- ACCU-CHEK Complete diabetes monitoring kit/ care kit/ insulin pump therapy kit, Cat. no 515; Ref. nos. 03144852001 and 12031981001 with meter model no. 200 and Ref. no. 03144852001 with meter model no. 250.
- Status
- Terminated
- Initiated
- 2006-06-22
- Posted
- 2006-08-05
- Terminated
- 2008-04-07
- Reason
- The meter gives an error message that can "actually" mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that there is a bad strip.
- Root cause
- Other
- Action
- A recall notification letter dated April 24, 2006 was sent to each customer alerting them to the fact that this error code has a dual meaning. New software will be installed in all meters when it becomes available.
- Quantity
- 55,189 meters (for all Recalls Z-1354-1371-06)
- Distribution
- Worldwide, USA, Germany, Guam, North Mariana Islands, Panama and Virgin Islands.
- Lot, serial or model codes
- All units.
- 510(k) numbers
- ["K973662"]
- PMA numbers
- not on file
- Product code
- LFR
- Firm FEI
- 1823260
- Firm city
- Indianapolis
- Firm state
- IN
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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