Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported March 23, 2022
BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack
Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challen…
Bio-Rad Laboratories, Inc. recalled BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack - a moderate-severity action.
BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack was recalled by Bio-Rad Laboratories, Inc. in March 23, 2022. Reason: Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syp…. Check the official notice for the remedy. Verify recall #Z-0806-2022 with the FDA Devices before acting.
The recall
Bio-Rad Laboratories, Inc. issued this moderate-severity FDA Devices recall-Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syp….
- Moderate
- severity level
- Class II
- classification
- March 23, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0806-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0806-2022) was formally reported on March 23, 2022, with the manufacturer initiating the action on February 8, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. Bio-Rad Laboratories, Inc. is listed as the recalling firm, operating out of Redmond, WA. Federal records list the affected scope as 9,426 packs (U.S.).
The documented reason for this recall is: Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to produce RPR reagents that consist… Distribution data in the federal record shows the product reached: Worldwide distribution U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, 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, 6 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 - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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
9,426 packs (U.S.)
Related Recalls
6
6 from same agency
Product description
BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack
Reason for recall
Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to produce RPR reagents that consistently meet stability specifications
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0806-2022 |
| Date reported | March 23, 2022 |
| Date initiated | February 8, 2022 |
| Recalling firm | Bio-Rad Laboratories, Inc. |
| Firm location | Redmond, WA |
| Affected scope | 9,426 packs (U.S.) |
| Distribution | Worldwide distribution U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, 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-0806-2022) 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? ▼
BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack. Recalled by Bio-Rad Laboratories, Inc.. Units affected: 9,426 packs (U.S.).
Why was this product recalled? ▼
Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to produce RPR reagents that consistently meet stability specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 23, 2022. Severity: Moderate. Recall number: Z-0806-2022.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of France, Germany, Italy, Spain, Saudi Arabia, and United Arab Emirates..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0806-2022) 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.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Compare this recall with FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access… →
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 March 23, 2022. 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 August 2026.