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Device recall: Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry Catalog Number:1360 Chek-Stix¿ Positive and N
FDA enforcement event 63809 is a device recall by Siemens Healthcare Diagnostics Inc of Norwood, MA, initiated 21 Nov 2012 and classified Class II, with 7 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 823 device enforcement events initiated in 2012 carry the same class.
Status: Terminated, terminated 6 Nov 2014. Initiation: voluntary: firm initiated. Siemens Healthcare Diagnostics Inc has 333 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Siemens Healthcare Diagnostics Inc, Norwood, MA.
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)."
Distribution
"Worldwide Distribution - USA (nationwide) and internationally to Canada, Aruba, Brazil, Denmark, India, Mexico, New Zealand, Singapore,Thailand, Bahamas, South Wales, and Hong Kong,"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0635-2013 | Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry Catalog Number:1360 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,… | 7865 | Class III | Terminated | 16 Jan 2013 |
| Z-0636-2013 | Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine Chemistry Catalog Number: 5019 When used with the CLINITEK ATLAS¿ Automated urine Chemistry Analyzer and CLINITEK ATLAS¿ 10 reagent Pak, CLINITEK ATLAS¿ Positive and Negative Control Strips provide defined results for color, clarity, glucose,… | 6466 | Class III | Terminated | 16 Jan 2013 |
| Z-0637-2013 | Siemens Chek-Stix Combo Pak Catalog Number: 1364 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… | 16711 | Class III | Terminated | 16 Jan 2013 |
| Z-0638-2013 | Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry (Distributed OUS Only) Catalog Number: 1360L 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… | 700 | Class III | Terminated | 16 Jan 2013 |
| Z-0639-2013 | Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364M 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… | 325 | Class III | Terminated | 16 Jan 2013 |
| Z-0640-2013 | 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… | 1130 | Class II | Terminated | 16 Jan 2013 |
| Z-0641-2013 | 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… | 4642 | Class III | Terminated | 16 Jan 2013 |
Context
Other enforcement events for Siemens Healthcare Diagnostics Inc
All 333 events for Siemens Healthcare Diagnostics Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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)."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - USA (nationwide) and internationally to Canada, Aruba, Brazil, Denmark, India, Mexico, New Zealand, Singapore,Thailand, Bahamas, South Wales, and Hong Kong,"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 6 Nov 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.