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

2 recalls on file across devices, 0 of them Class I and 0 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic caClass IISep 18, 2024The reason for this recall is PTS Diagnostics, Inc. received	The reason for this recall is PTS Diagnostics, Inc. received complaints of non-matching cartridge and analyzer	Class IIDevices	Sep 18, 2024
PTS Panels CHOL+GLU Test Strips (REF 1765)Class IIIAug 16, 2022Incorrect instructions for use were packaged into the final	Incorrect instructions for use were packaged into the final product.	Class IIIDevices	Aug 16, 2022