CardioChek recallZ-0834-2020 · Polymer Technology Systems, Inc. · initiated Dec 2, 2019

Why it was recalled

One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to make reverse contact. This reverse contact can cause a potential for overheating.

FDA root cause category: Device Design

What the company is doing

Urgent Medical Device Correction notification letters dated 11/15/19 were sent to customers. Actions to be taken by the Customer/Distributor/User: 1. Immediately check your inventories and apply the sticker/labels as directed. If you are an end user: Please adhere one label to the outside of the battery door compartment of your analyzer and apply the other label to the analyzer user guide. If you are a distributor: Please remove the tape liner on the back of the large sticker leaving both small labels intact for the end user to apply. Apply the large sticker to the top panel of the analyzer box, and press firmly. 2. If you have further distributed this product, immediately identify the users and notify them at once of this product correction. Forward this notice, stickers, and response form to all customers/users who did, or who may have, received, this product. 3. Once you have taken the appropriate action, please fill out the attached response form and return it to PTS Diagnostics via the information below. It is important that you complete and return the response form, even if you do not have affected product on hand. 4. Please contact PTS for additional stickers and a PDF version of this letter and response form, if needed. Thank you for your prompt action, and we apologize for any inconvenience this issue may have caused you and your facility. If you have any questions, please contact Customer Service, Monday through Friday, 8:00 AM to 5:00 PM, Eastern Time at +1 319-870-5610 or 877-870-5610 (U.S. toll-free), or via email at [email protected].

Recall details

Recall number

Z-0834-2020

Status

Terminated

Initiated by the company

Dec 2, 2019

Recalling firm

Polymer Technology Systems, Inc.

Quantity

44,448

Product code

NBW

FDA submissions

K140068

Distribution

The products were distributed US Nationwide. The products were distributed to the following foreign countries: Australia, Austria, Belgium, Bermuda, Canada, China, Chile, Costa Rica, Cayman Islands, Czech Republic, England, Finland, France, Germany, Greece, Hong Kong, India, Iraq, Italy, Jordan, Lebanon, Lithuania, Mexico, Morocco, Panama, Philippines, Poland, Qatar, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Trinidad, UAE.

Product description

Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• CardioChek 5700534

  Henry Schein, Inc. · TUBE, COLLECTION, CAPILLARY BLOOD
  1 recall0 reports

Product lines

• CardioChekHenry Schein, Inc. · 3 models · 5 reports · 3 recalls

Other devices under the same FDA submission

1 device cleared under K140068 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• CardioChek 5700411

  Henry Schein, Inc. · ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL
  1 recall5 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 84274).

• Z-0832-2020 · Terminated
  PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying case, Reference Numbers 2700
• Z-0833-2020 · Terminated
  PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, without box or carrying case, Reference Numbers 2702
• Z-0835-2020 · Terminated
  Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying case, Reference Number 4060 HS, 570-0411