Roche Diagnostics Corporation: CoaguChek¿ XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160; CoaguChek XS PT Test 6 Strips, Catalog Number: 04625374160; Co

Is my product affected?

CoaguChek¿ XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160; CoaguChek XS PT Test 6 Strips, Catalog Number: 04625374160; CoaguChek XS PT Test 24 Tests, Catalog Number: 07797826160;

• UPC 04625375160
• UPC 04625374160
• UPC 07797826160

Check against the official notice below — it lists the full affected range.

What happened

Roche Diagnostics Corporation is recalling 1,163,952 boxes of CoaguChek XS System Prothrombin time test strips distributed nationwide. The affected products are CoaguChek XS PT Test 2X24 Strips (Catalog Number 04625315160), CoaguChek XS PT Test 6 Strips (Catalog Number 04625374160), and another variant (Catalog Number 07797826160). These test strips are affected if they bear any of the following lot numbers: 28124111, 28124121, 28631911, 28631921, 28631924, 28632021, 28632213, 28632312, 28632412, 29415113, 29415123, 29494221, 29494312, 29494613, 29494711, 29778721, 29779012, 29779213, 29779214, 30497213, 30497311, 30497413, 30497423, 30497515, 31404314, 31404821, 32264116, 32264212, 32264316, 32264317, 32264411, 32264421, 33045913, 33046011, 33046113, 33046312, 33046314, 33046321, 33046322, 33449612, 33449712, 33449723, or 33449817.

The affected test strips may produce abnormally high INR (International Normalized Ratio) test results. The source document does not specify what action affected consumers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Abnormally high INR test results with the affected CoaguChek test strips

Details from the source

Reason for recall: Abnormally high INR test results with the affected CoaguChek test strips Distribution: Nationwide Quantity: 1,163,952 boxes Lot/code info: 1) Catalog Number 04625375160 Lot Numbers authorized for use within the USA: 28124111 28124121 28631911 28631921 28631924 28632021 28632213 28632312 28632412 29415113 29415123 29494221 29494312 29494613 29494711 29778721 29779012 29779213 29779214 30497213 30497311 30497413 30497423 30497515 31404314 31404821 32264116 32264212 32264316 32264317 32264411 32264421 33045913 33046011 33046113 33046312 33046314 33046321 33046322 33449612 33449712 33449723 33449817 2) Catalog Number 04625374160 Lot Numbers authorized for use within the USA: 28124111 28124121 28631911 28631921 28631924 28632021 28632213 28632312 28632412 29415113 29415123 29494221 29494312 29494613 29494711 29778721 29779012 29779213 29779214 30497213 30497311 30497413 30497423 30497515 31404314 31404821 32264116 32264212 32264316 32264317 32264411 32264421 33045913 33046011 33046113 33046312 33046314 33046321 33046322 33449612 33449712 33449723 33449817 3) Catalog Number: 07797826160 Lot Numbers authorized for use within the USA: 28124111 28124121 28631911 28631921 28631924 28632021 28632213 28632312 28632412 29415113 29415123 29494221 29494312 29494613 29494711 29778721 29779012 29779213 29779214 30497213 30497311 30497413 30497423 30497515 31404314 31404821 32264116 32264212 32264316 32264317 32264411 32264421 33045913 33046011 33046113 33046312 33046314 33046321 33046322 33449612 33449712 33449723 33449817

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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