Z-2121-2017Class III

Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic cap. LEV2...

Name: Z-2121-2017 Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic cap. LEV2...
Creator: Medtest Holdings, Inc.
Published: 2014-05-15
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2014-05-15 / Terminated / root cause: design

FDA source

Medtest Holdings, Inc. began a recall of Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic cap. LEV2: Amber glass vial w/PP black plastic cap on 2014-05-15. FDA classified it as Class III and gives the reason as "The original mean assigned to the control too high, upon reassignment with additional data the new assigned mean was outside of the originally published range". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2121-2017
Classification: Class III
Status: Terminated
Initiated: 2014-05-15
Posted: 2017-05-20
Terminated: 2017-06-02
Recalling firm: Horiba Instruments Incorporated
Product: Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic cap. LEV2: Amber glass vial w/PP black plastic cap.
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: The original mean assigned to the control too high, upon reassignment with additional data the new assigned mean was outside of the originally published range.
Root cause tag: design
FDA root cause: Component design/selection
Action: Customers were notified on 05/5/14by sending a technical bulletin (via email, fax, US Mail and posting on website) to all customers and distributors that had received lot 303104 of C7590, lot 303105 of C7591 or C7592 kits with either lot since product was approved to ship. All product shipped after 05/15/2014 included the updated package inserts. Any questions concerning the implementation of the new controls ranges may be directed to Pointe Scientific's Technical Service Department at 1-800-757-5313. Thank you for your continued support of Pointe Scientific.
Quantity in commerce: 132919 Vol vials
Distribution: Nationwide
Product codes and lots: Model Number(s): C7590-50 (Chemistry Control Level I), C7591-50 (Chemistry Control Level II), and C7592-100 (Chemistry Control Level I and II).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2121-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2121-2017	Class III	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-20

Product code JJY

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)