Lower riskMedical device recall · FDA · Published March 2, 2018
BD MAX DNA MMK (SPC) Lab Reagent: Incorrect Diluent Volume Risk
Becton Dickinson recalls BD MAX DNA MMK (SPC) lab reagents from August 2014 due to incorrect primer/probe diluent volume in package inserts, potentially affecting assay results.
The package insert incorrectly lists the volume of the primer and probe diluent to use for the reconstitution of the master mix tube. Adding the incorrect amount of diluent could have an effect on the assay.
Becton Dickinson is recalling BD MAX DNA MMK (SPC) lab reagents from August 2014 because the package insert lists the wrong volume of diluent for reconstitution. This could cause assay errors if users add the incorrect amount of diluent. Read more at govinfonow.com/recall/71817-bd-max-dna-mmk-spc-lab-reagent-incorrect-diluent-volume.
“BD MAX DNA MMK (SPC) Lab Reagent: Incorrect Diluent Volume Risk.” GovInfoNow, updated August 27, 2026. https://govinfonow.com/recall/71817-bd-max-dna-mmk-spc-lab-reagent-incorrect-diluent-volume. Based on FDA recall #Z-1544-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1544-2018%22&limit=1).
The FDA announced on March 2, 2018, that Becton Dickinson & Co. is recalling BD MAX DNA MMK (SPC) For Laboratory Use due to an incorrect package insert listing the volume of primer and probe diluent. The error could affect assay results. Owners should stop using the product immediately.
How to tell if you have it
Brand: Becton Dickinson
Product: BD MAX DNA MMK (SPC) For Laboratory Use
Catalog number: 442829
Units affected: 13,898
The hazard
The package insert incorrectly lists the volume of the primer and probe diluent to use for the reconstitution of the master mix tube. Adding the incorrect amount of diluent could have an effect on the assay.
Context
GovInfoNow's records show Becton Dickinson & Co. has 43 other recalls on record since June 1, 2017. Recent brand recalls include a BD GasP system recall on April 7, 2026, and a BD Kiestra Isolate Suspension Cuvette Array recall on October 23, 2025. Other recent recalls of similar products include a Beckman Coulter DxH Diluent recall (November 10, 2025), a Medline Blood Culture Kit recall (December 24, 2025), and a Milestone Vacuum Bag SU Large Specimen Container recall (March 9, 2026).
How to tell if you have this one
Check for BD MAX DNA MMK (SPC) reagents with catalog number 442829 purchased since August 20, 2014. The product is intended for laboratory use only.
Brand
Becton Dickinson
Category
Medical device
FDA recall event · 2 products
All 2 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 III
Status
Terminated
Distribution
Distributed to accounts in 8 states: CA, FL, NJ, NY, OR, PA, VA, and WI. International distribution to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Europe, Hong Kong, Japan, Singapore, Taiwan, and Thailand.
Recall number
Product, codes & lots
Quantity
Z-1544-2018
BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829; All since 08/20/2014
13,898
Z-1545-2018
BD MAX DNA MMK Lab Use, catalog no. 442828; All since 08/20/2014
N/A
Based on the official FDA remedy
What to do — step by step
Check Package Insert
Verify the diluent volume listed in the package insert matches the correct amount for the reconstitution process.
Where it went and when
Where it was distributed
Distributed in 8 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “Distributed to accounts in 8 states: CA, FL, NJ, NY, OR, PA, VA, and WI. International distribution to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Europe, Hong Kong, Japan, Singapore, Taiwan, and Thailand.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Florida, New Jersey, New York, Oregon, Pennsylvania, Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 4 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-1544-2018 (March 2, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1544-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 27, 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.