ADVIA Centaur Systems Progesterone Kit, (5-pack Ref); In Vitro Diagnostic Catalog number: 02177364; SMN: 10333111.
Reported: March 11, 2015 Initiated: January 27, 2015 #Z-1231-2015
Product Description
ADVIA Centaur Systems Progesterone Kit, (5-pack Ref); In Vitro Diagnostic Catalog number: 02177364; SMN: 10333111.
Reason for Recall
ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL (95.4 nmol/L)
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc
- Units Affected
- 1719 kits
- Distribution
- Worldwide Distribution-US (nationwide), Austria, Bahrain, Belgium, Bulgaria, Brazil, Canada, Chile, Colombia, Croatia, Cyprus, Czech, Republic, Denmark, Egypt, Estonia, France, Georgia, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Iran, Iraq, Ireland, Italy, Japan, Jordan, Kazakhstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Peru, Poland, Portugal, Qatar, Romania, Russian Federation, Serbia, Slovakia, Spain, South America, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and Vatican.
- Location
- East Walpole, MA
Frequently Asked Questions
What product was recalled? ▼
ADVIA Centaur Systems Progesterone Kit, (5-pack Ref); In Vitro Diagnostic Catalog number: 02177364; SMN: 10333111.. Recalled by Siemens Healthcare Diagnostics, Inc. Units affected: 1719 kits.
Why was this product recalled? ▼
ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL (95.4 nmol/L)
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 11, 2015. Severity: Moderate. Recall number: Z-1231-2015.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11