CLASS III Device recall · Reported 16 Jan 2013 · FDA Enforcement Report
Siemens Chek-Stix Combo Pak (Distributed OUS) recalled
Siemens Healthcare Diagnostics is recalling Siemens Chek-Stix Combo Pak (Distributed OUS), distributed nationwide in the US. The recall was initiated on 21 Nov 2012 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0641-2013
- FDA event ID
- 63809
- Recalling firm
- Siemens Healthcare Diagnostics, Norwood, MA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 21 Nov 2012
- FDA classified
- 4 Jan 2013
- Reported
- 16 Jan 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 21 Nov 2012 | Recall initiated by company | |
| 4 Jan 2013 | Classified by FDA | +44 days |
| 16 Jan 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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 25¿C (77¿F).
Product as listed by the FDA
Siemens Chek-Stix Combo Pak (Distributed OUS) Catalog Number: 1364E 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
Where it was distributed
Worldwide Distribution - USA (nationwide) and internationally to Canada, Aruba, Brazil, Denmark, India, Mexico, New Zealand, Singapore,Thailand, Bahamas, South Wales, and Hong Kong,
Questions about this recall
Is Siemens Chek-Stix Combo Pak (Distributed OUS) recalled?
Yes. Siemens Healthcare Diagnostics recalled Siemens Chek-Stix Combo Pak (Distributed OUS) on 21 Nov 2012. The recall is Class III and its status is Terminated. Recall number Z-0641-2013.
Why was it recalled?
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 25¿C (77¿F).
Which lots are affected?
Carton/Bottle Lot Number: C0099091C P0099091C C0100101F P0100101F C9101022I P9101022I C0103042D P0103042D C0106062E P0106062E
Where was it sold?
Worldwide Distribution - USA (nationwide) and internationally to Canada, Aruba, Brazil, Denmark, India, Mexico, New Zealand, Singapore,Thailand, Bahamas, South Wales, and Hong Kong,
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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