Z-3032-2026Class II

healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number...

Name: Z-3032-2026 healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number...
Creator: Healthmark Industries Co., Inc.
Published: 2026-07-29
License: https://open.fda.gov/license/

Healthmark Industries Co., Inc. / initiated 2026-07-29 / Open, Classified / root cause: manufacturing process

FDA source

Healthmark Industries Co., Inc. began a recall of healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number PT-SQ-001 on 2026-07-29. FDA classified it as Class II and gives the reason as "Test manufactured with an expired ingredient which may present as either a false negative or positive". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3032-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-29
Posted: 2026-08-26
Recalling firm: Healthmark Industries Co., Inc.
Product: healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number PT-SQ-001
Product code: SDC Qualitative Cleaning Process Protein Indicator
Reason for recall: Test manufactured with an expired ingredient which may present as either a false negative or positive.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: GETINGE issued an URGENT MEDICAL DEVICE RECALL/REMOVAL to its consignees on 7/29/2026 via email and telephone. The notice explained the issue, risks to health, and requested the following: "Customer Actions Our records indicate that your facility has received one or more of the affected devices that are affected by this notice. As a result, Healthmark requests that your facility takes the following actions: 1. Ensure all affected product in your facility s inventory is no longer in use and has been properly quarantined. 2. Please ensure this message is forwarded to any individuals who need notification within your organization or any organization where the affected devices have been transferred. 3. Contact Customer Service via email at [email protected] or 800-521-6224 to return your unused affected product or if you have any questions. 4. Please fill out the Customer Response Form using the link or QR code provided below. Getinge has partnered with IQVIA MedTech to coordinate the recall response process."
Quantity in commerce: 53 units
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, France, Hong Kong, South Korea.
Product codes and lots: Serial/Lot Numbers: 200035, 200036, 200037, 200038, 200039, 200040, 30028.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3032-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3031-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-26
Z-3032-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-26

Product code SDC

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 2026-09-12. View this recall on fda.gov (opens on fda.gov)