FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics Inc: Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364N Chek-Stix Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes
- Recall number
- Z-0640-2013
- Recalling firm
- Siemens Healthcare Diagnostics Inc
- Product
- Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364N Chek-Stix Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes
- Status
- Terminated
- Initiated
- 2012-11-21
- Posted
- 2013-01-04
- Terminated
- 2014-11-06
- Reason
- When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25C (77F).
- Root cause
- Nonconforming Material/Component
- Action
- Siemens issued An Urgent Field Safety Notice via e-mail to all affected SiemensHealthcare Diagnostics Regional offices on November 21, 2012 both in the United States and foreign accounts. This notice informed customers of the issue with the CLINITEK Atlas and Chek-Stix Positive Urinalysis Control Solutions When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25C (77F). You can use the reconstituted positive control solution for up to eight hours if the solution is held at 25C (77F) or lower. If the operating temperature is greater than 25C and lower than 30C (77F and 86F), the solution can be used for up to two hours. For questions regarding this recall call 781-269-3158.
- Quantity
- 1130
- Distribution
- Worldwide Distribution - USA (nationwide) and internationally to Canada, Aruba, Brazil, Denmark, India, Mexico, New Zealand, Singapore,Thailand, Bahamas, South Wales, and Hong Kong,
- Lot, serial or model codes
- Carton/BottleLot Number: C0099091A P0099091A C0100101 H P0100101 H C0103042C P0103042C
- 510(k) numbers
- ["K943780"]
- PMA numbers
- not on file
- Product code
- JJW
- Firm FEI
- 3002637618
- Firm city
- Norwood
- Firm state
- MA
- 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