Z-2631-2017 Class III Terminated
FDA device recall Z-2631-2017 was initiated by Medtest Holdings, Inc. on July 21, 2009 and is designated Class III. Reason for recall: Individual vials of calibrator and standard were mislabeled; specifically the units on the vial labels are incorrectly listed as mg/dl when the correct unit is mg/L. The recall status is terminated (terminated July 24, 2017). Affected quantity: 323 vials.
Recall Details
- Product Type
- Devices
- Report Date
- July 5, 2017
- Initiation Date
- July 21, 2009
- Termination Date
- July 24, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 323 vials
Product Description
Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS) Wide Range Standard Set 5 Levels of 1 x 2 ml ready to use calibrator or standard The Pointe Scientific CRP (HS) Wide Range Multi-Calibrator Set is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use only. The Pointe Scientific CRP (HS) Wide Range Multi-Standard Set Is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use only
Reason for Recall
Individual vials of calibrator and standard were mislabeled; specifically the units on the vial labels are incorrectly listed as mg/dl when the correct unit is mg/L.
Distribution Pattern
Worldwide Distribution - US including CA, MS, NJ, PA, HI, MD, FL, OK, NV. Foreign Distribution to CHILE
Code Information
Model #'s C7568-CTL and C7568-STD Lots: C7568-STD: 717303-131. Exp 6/2009. C7568-CTL: 902701-111 and 902701-131. Exp 1/2011.