The Recall Desk
HighFDA (Devices)·Z-0962-2019·Announced 2019-03-06

Organon Teknika Recalls Vitek 2 Reagent Cards Due to Seal Integrity Issues

Organon Teknika Inc is recalling 129,321 cartons of Vitek 2 reagent cards worldwide due to compromised top seal integrity that may cause inaccurate test results.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential for inaccurate diagnostic results (false negatives/positives) which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Organon Teknika Inc is recalling 129,321 cartons of Vitek 2 reagent cards distributed worldwide. The recall involves multiple specific card types, including GN ID, GP ID, ANC ID, and various AST panels, with specific lot numbers listed in the agency's structured data.

The recall was initiated due to a potential for compromised test card Top Seal Integrity. This defect could yield false resistance for antibiotics on the AST panel, cause a false negative ESBL Test, or result in a false positive urea (URE) reaction on ID cards.

No specific consumer action is detailed in the provided source text beyond the recall notice itself. Healthcare facilities and distributors should verify their inventory against the listed lot numbers and reference codes.

The recalled product

Product
Vitek 2 reagent cards: a) GN ID, REF 21341, b) GP ID, REF 21342, c) ANC ID, REF 21347, d) AST-GNOR, REF 22000, e) AST-GP67, REF 22226, f) AST-P612, REF 22359, g) AST-XN01, REF 410025, h) AST-N222, REF 413083, i) AST-N223, REF 413110, j) AST-N226, REF 413143, k) AS
Manufacturer
Organon Teknika Inc
Category
Medical Device — In Vitro Diagnostics
Hazard
Affected units
129,321

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • a) GN ID
  • REF 21341: Lot Numbers: 2410602403
  • 2410624103
  • 2410632203
  • 2410635203
  • 2410636203
  • 2410637203 b) GP ID
  • REF 21342
  • Lot Numbers: 2420806103
  • 2420818403
  • 2420822203 c) ANC ID
  • REF 21347
  • Lot Numbers: 2440811203 d) AST-GNOR
  • REF 22000
  • Lot Numbers: 1010810203 e) AST-GP67
  • REF 22226
  • Lot Numbers: 1320808103
  • 1320816203
  • 1320820403 f) AST-P612
  • REF 22359

Distribution

Distribution scope not specified by the agency.

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