Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. recall records

0 reported ongoing

2 records in this archive. Latest source date Sep 18, 2024.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent strips, and (3) a sample di...

The reason for this recall is PTS Diagnostics, Inc. received complaints of non-matching cartridge and analyzer codes within the product test system box. Use of cartridges and analyzers with non-matching codes may result in inaccurate test results as compone...

Class IIReported completed

Distribution: Worldwide distribution - US Nationwide and the countries of Japan, South Africa.

Official source for A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the mon...

Reasons in these listed records

  • The reason for this recall is PTS Diagnostics, Inc. received complaints of non-matching cartridge and analyzer codes within the product test system box. Use of cartridges and analyzers with non-matching codes may result in inaccurate test results as components within each lot ...
  • Incorrect instructions for use were packaged into the final product.

These examples come from this result page and are not a ranking of every recall reason.

Checking Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.

Is there a recall on polymer technology systems, inc. dba pts diagnostics, inc. right now?

This archive contains 2 records, including 0 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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