Recall Z-0639-2013— Siemens Healthcare Diagnostics Inc
Class III · Terminated
Class III FDA medical device recall by Siemens Healthcare Diagnostics Inc, initiated 2012-11-21, terminated 2014-11-06. It names one FDA 510(k) clearance: K943780. Product: 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 (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes. 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 25¿C (77¿F)..
- Recalling firm
- Siemens Healthcare Diagnostics Inc
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2012-11-21
- Terminated
- 2014-11-06
- Firm location
- Norwood, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.