The Recall Desk

Manufacturer

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

2 recalls in our database name Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2024-10-30

Of the 2 recalls from Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • HighFDA (Devices)·Z-0223-2025·2024-10-30

    A1CNow+ Multi-Test HbA1c System recalled due to mismatched cartridge and analyzer codes

    Polymer Technology Systems recalled 2,452 A1CNow+ diabetes test systems due to mismatched cartridge and analyzer codes. Non-matching components may produce inaccurate blood glucose readings.

    Product
    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 dilution kit for: collecting the blood sample, mixing the sample with the required pre-treatment solution
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1741-2022·2022-09-21

    PTS Panels CHOL+GLU Test Strips Recalled for Incorrect Instructions

    PTS Panels CHOL+GLU Test Strips (lot A202) are recalled because incorrect instructions for use were packaged with the product. Distribution includes the US, Japan, and Russia.

    Product
    PTS Panels CHOL+GLU Test Strips (REF 1765)
    Category
    Medical Device
    Distribution
    Distributed nationwide