Lower risk Medical device recall · FDA · Published October 20, 2022

Remel Sensititre STP6F Gram Negative IVD AST Recall: False Results Risk

Remel recalls Sensititre STP6F Gram Negative IVD AST plates with specific lot numbers due to risk of false susceptible results for certain bacteria when tested with specific antibiotics.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0334-2023Medical device Remel ›

Lower-risk recall

An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.

Take action

Contact the company

Recalling firmRemel Inc12076 Santa Fe Trail Dr · Lenexa, KS 66215-3519

✎ GovInfoNow plain-language explainer

Remel is recalling Sensititre STP6: Gram Negative IVD AST plates that may give false results for certain bacteria when tested with specific antibiotics. This could lead to incorrect treatment decisions if used in medical testing. Read more at govinfonow.com/recall/59826-remel-sensititre-stp6f-gram-negative-ivd-ast-recall-false-results.

Source Summary by GovInfoNow · govinfonow.com/recall/59826-remel-sensititre-stp6f-gram-negative-ivd-ast-recall-false-results · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0334-2023

Cite this page

“Remel Sensititre STP6F Gram Negative IVD AST Recall: False Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59826-remel-sensititre-stp6f-gram-negative-ivd-ast-recall-false-results. Based on FDA recall #Z-0334-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0334-2023%22&limit=1).

The FDA announced on October 20, 2022, that Remel Inc is recalling Thermo SCIENTIFIC Sensititre STP6F Gram Negative IVD AST plates due to a Class I hazard. The recall affects 2,656 units distributed nationwide.

How to tell if you have it

Brand: Remel
Product: Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST
Lot Numbers: B2314, B2174, B2036, B1346, B1183, B1115, B1027
Units affected: 2,656

The hazard

An internal technical investigation confirmed that the plates may lead to false susceptible results for Proteae Tribe bacteria when tested with specific antibiotics. The FDA classified this as a Class I recall.

Context

GovInfoNow's records show Remel, Inc has 22 other recalls on record since November 2, 2017. Other recent recalls of similar products include the Biomerieux VITEK 2 AST-N461 Test Kit Recall (July 24, 2026), the Biomerieux VITEK 2 AST-N447 Kit Recall (June 4, 2026), and the Remel Neisseria meningitidis Gp C 2ml/VL recall (July 17, 2026).

How to tell if you have this one

Check the lot numbers on the plate: B2314, B2174, B2036, B1346, B1183, B1115, or B1027. These plates are sold by Remel for medical testing.

Brand
Remel
Category
Medical device

FDA recall event · 9 products

All 9 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class I
Status
Terminated
Distribution
US Nationwide Distribution

Recall number	Product, codes & lots	Quantity
Z-0327-2023	Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST; Lot Numbers: B2232B, B2197, B2012, B1355, B1181, B1173, B1125A	1917 units
Z-0328-2023	Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST; Lot Numbers: B2247, B2096, B1445, B1263, B1176, B0503A	2471 units
Z-0329-2023	Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD AST; Lot Numbers: B2317, B2267, B2251, B2177, B2086, B2037, B2034B, B1476, B1424, B1384, B1286, B1215, B1182, B1104, B1051, B1021	8073 units
Z-0330-2023	Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST; Lot Numbers: B2206A, B2035A, B1333, B1144A, B0483	665 units
Z-0331-2023	Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST; Lot Numbers: B2125, B2115	588 units
Z-0332-2023	Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST; Lot Numbers: B2281, B2151A, B2034, B1453	1647 units
Z-0333-2023	Thermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD AST; Lot Numbers: B2311B	70 units
Z-0334-2023	Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST; Lot Numbers: B2314, B2174, B2036, B1346, B1183, B1115, B1027	2656 units
Z-0335-2023	Thermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD AST; Lot Numbers: B2265A	9 units

Based on the official FDA remedy

What to do — step by step

Check Lot Numbers
Identify the lot number on the Sensititre STP6F plate to see if it matches the recalled numbers: B2314, B2174, B2036, B1346, B1183, B1115, or B1027.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 23 months after the firm started it.

Oct 20, 2022Firm started the recall
Dec 7, 2022FDA classified it Class I
Dec 14, 2022Published in FDA’s Enforcement Report
Sep 30, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using these plates immediately?

The recall does not require immediate stop use; check the lot numbers to determine if your plate is affected.

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Link to this recall

<a href="https://govinfonow.com/recall/59826-remel-sensititre-stp6f-gram-negative-ivd-ast-recall-false-results">Remel Sensititre STP6F Gram Negative IVD AST Recall: False Results Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0334-2023 (October 20, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0334-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.