Reported Jan 16, 2013 · Terminated
Siemens Chek-Stix Combo Pak Catalog Number: 1364 Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry:…
Siemens Healthcare Diagnostics Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics Inc · 2 Edgewater Dr · Norwood, MA · 02062-4637
Is this the product you have?
- Siemens
- Chek-Stix Combo Pak Catalog Number1364 Chek-Stix¿ Positive and Negative
- Control Strips for Urine ChemistryWhen 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
- Lot codes and dates
- Carton/Bottle Lot Number
C9093061CP9093061CC9094081JP9094081JC0100101DP0100101DC0097091EP0097091EC9101022EP9101022EC0099091DP0099091DC0100101EP0100101EC9101022HP9101022HC9101022JP9101022JC0103042BP0103042BC0103042GP0103042GC0106062DP0106062DC9105052CP9105052C
- Carton/Bottle Lot Number
- Amount recalled
- 16711
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
- Nationwide
Why it was 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).
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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