Z-2631-2017Class III

Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS) Wide Range Standard Set 5...

Name: Z-2631-2017 Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS) Wide Range Standard Set 5...
Creator: Medtest Holdings, Inc.
Published: 2009-07-21
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2009-07-21 / Terminated / root cause: labeling and UDI

FDA source

Medtest Holdings, Inc. began a recall of 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... on 2009-07-21. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2631-2017
Classification: Class III
Status: Terminated
Initiated: 2009-07-21
Posted: 2017-06-26
Terminated: 2017-07-24
Recalling firm: Horiba Instruments Incorporated
Product: 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
Product code: DCK C-Reactive Protein, Antigen, Antiserum, And Control
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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Technical Bulletin sent notification on July 21, 2009, to affected consignees via e-mail, fax and US Mail. The recall notification included a description of the reason for the recall, affected product, and consignee responsibilities. Customers with questions were instructed to contact Pointe Scientific's Technical Service Department at 1-800-757-5313. For questions regarding this recall call 800-757-5313.
Quantity in commerce: 323 vials
Distribution: Worldwide Distribution - US including CA, MS, NJ, PA, HI, MD, FL, OK, NV. Foreign Distribution to CHILE
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2631-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2631-2017	Class III	Terminated	Voluntary: Firm initiated	2017-07-05	2017-06-26

Product code DCK

K030545Class IICrp-Latex (Ii)x2 Seiken Assay KitDenka Seiken Co., Ltd. / cleared 2003-06-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)