Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 26, 2018
VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these susceptibility products: Catalog # 410028, VITEK 2 AST-ST01 Catalog # 420915, VITEK 2 AST-ST02 Catalog # 421040, VITEK 2 AST-ST03 The VITEK 2 Streptococcus Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of S. pneumoniae, beta-hemolytic Streptococcus, and Viridans Streptococcus to antimicrobial agents when used as ins
False resistant results for Streptococcus anginosus and Streptococcus constellatus strains were reported.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
bioMerieux, Inc. recalled VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these susceptibil… - a moderate-severity action.
VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these susceptibil… was recalled by bioMerieux, Inc. in December 26, 2018. Reason: False resistant results for Streptococcus anginosus and Streptococcus constellatus strains were reported.. Check the official notice for the remedy. Verify recall #Z-0618-2019 with the FDA Devices before acting.
The recall
bioMerieux, Inc. issued this moderate-severity FDA Devices recall-False resistant results for Streptococcus anginosus and Streptococcus constellatus strains were reported..
- Moderate
- severity level
- 184K units
- affected scope
- Class II
- classification
- December 26, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0618-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0618-2019) was formally reported on December 26, 2018, with the manufacturer initiating the action on October 22, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. bioMerieux, Inc. is listed as the recalling firm, operating out of Durham, NC. Federal records list the affected scope as 184,374, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: False resistant results for Streptococcus anginosus and Streptococcus constellatus strains were reported. Distribution data in the federal record shows the product reached: Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, T…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
184,374
Related Recalls
6
3 from same agency
Product description
VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these susceptibility products: Catalog # 410028, VITEK 2 AST-ST01 Catalog # 420915, VITEK 2 AST-ST02 Catalog # 421040, VITEK 2 AST-ST03 The VITEK 2 Streptococcus Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of S. pneumoniae, beta-hemolytic Streptococcus, and Viridans Streptococcus to antimicrobial agents when used as instructed.
Reason for recall
False resistant results for Streptococcus anginosus and Streptococcus constellatus strains were reported.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0618-2019 |
| Date reported | December 26, 2018 |
| Date initiated | October 22, 2018 |
| Recalling firm | bioMerieux, Inc. |
| Firm location | Durham, NC |
| Affected scope | 184,374 |
| Distribution | Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, W… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0618-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these susceptibility products: Catalog # 410028, VITEK 2 AST-ST01 Catalog # 420915, VITEK 2 AST-ST02 Catalog # 421040, VITEK 2 AST-ST03 The VITEK 2 Streptococcus Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of S. pneumoniae, beta-hemolytic Streptococcus, and Viridans Streptococcus to antimicrobial agents when used as instructed.. Recalled by bioMerieux, Inc.. Units affected: 184,374.
Why was this product recalled? ▼
False resistant results for Streptococcus anginosus and Streptococcus constellatus strains were reported.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 26, 2018. Severity: Moderate. Recall number: Z-0618-2019.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV, WY including Puerto Rico and to countries of:Algeria, Angola, Azerbaijan, Bahrain, Bangladesh, Belarus, Sarl, Benin, Bosnia-Herz, Cameroon, Chad, Cote d'Ivoire, Croatia, Dem. Rep. Congo, Egypt, , Georgia, Guam, Ethiopia, Iraq, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, UAB, Lithuania, Macedonia, Malta, Mongolia, Morocco, Mozambique, Niger, Oman, Pakistan, Palestine, Qatar, Romania, Saudi Arabia, Senegal, Serbia, Slovenia, Sri Lanka, Tunisia, Ukraine, Gabon, and Zimbabwe..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0618-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 26, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.