Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported September 30, 2015
CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Catalog number 340133 in vitro diagnostic used in Hematology: The SK3 monoclonal antibody reacts with human CD4, a 59-kDa cell surface receptor expressed by a majority of thymocytes, a subpopulation of mature T helper cells, and at low levels on monocytes. CD4 is a receptor for the human immunodeficiency virus (HIV).
CD4 FITC label contains an error in the Spanish small text - it states CD8 FITC.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Becton, Dickinson and Company, Bd Biosciences recalled CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Catalog number 3… - a low-severity action.
CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Catalog number 3… was recalled by Becton, Dickinson and Company, Bd Biosciences in September 30, 2015. Reason: CD4 FITC label contains an error in the Spanish small text - it states CD8 FITC.. Check the official notice for the remedy. Verify recall #Z-2817-2015 with the FDA Devices before acting.
The recall
Becton, Dickinson and Company, Bd Biosciences issued this low-severity FDA Devices recall-CD4 FITC label contains an error in the Spanish small text - it states CD8 FITC..
- Low
- severity level
- 128 units
- affected scope
- Class III
- classification
- September 30, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2817-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2817-2015) was formally reported on September 30, 2015, with the manufacturer initiating the action on August 27, 2015. It is classified under Low severity (Class III), with a current status of Terminated. Becton, Dickinson and Company, Bd Biosciences is listed as the recalling firm, operating out of San Jose, CA. Federal records list the affected scope as 128 units.
The documented reason for this recall is: CD4 FITC label contains an error in the Spanish small text - it states CD8 FITC. Distribution data in the federal record shows the product reached: Worldwide Distribution. US nationwide (TX, CA, NC, OH, SD, PA, CT, UT, MD, TX, GA), Argentina, Taiwan, Australia, Japan, China, New Zealand, Chile and Colombia.. 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 low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
128 units
Related Recalls
6
3 from same agency
Product description
CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Catalog number 340133 in vitro diagnostic used in Hematology: The SK3 monoclonal antibody reacts with human CD4, a 59-kDa cell surface receptor expressed by a majority of thymocytes, a subpopulation of mature T helper cells, and at low levels on monocytes. CD4 is a receptor for the human immunodeficiency virus (HIV).
Reason for recall
CD4 FITC label contains an error in the Spanish small text - it states CD8 FITC.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-2817-2015 |
| Date reported | September 30, 2015 |
| Date initiated | August 27, 2015 |
| Recalling firm | Becton, Dickinson and Company, Bd Biosciences |
| Firm location | San Jose, CA |
| Affected scope | 128 units |
| Distribution | Worldwide Distribution. US nationwide (TX, CA, NC, OH, SD, PA, CT, UT, MD, TX, GA), Argentina, Taiwan, Australia, Japan, China, New Zealand, Chile and Colombia. |
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-2817-2015) 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? ▼
CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Catalog number 340133 in vitro diagnostic used in Hematology: The SK3 monoclonal antibody reacts with human CD4, a 59-kDa cell surface receptor expressed by a majority of thymocytes, a subpopulation of mature T helper cells, and at low levels on monocytes. CD4 is a receptor for the human immunodeficiency virus (HIV).. Recalled by Becton, Dickinson and Company, Bd Biosciences. Units affected: 128 units.
Why was this product recalled? ▼
CD4 FITC label contains an error in the Spanish small text - it states CD8 FITC.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 30, 2015. Severity: Low. Recall number: Z-2817-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution. US nationwide (TX, CA, NC, OH, SD, PA, CT, UT, MD, TX, GA), Argentina, Taiwan, Australia, Japan, China, New Zealand, Chile and Colombia..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2817-2015) 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 September 30, 2015. 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.